The Effect of Extract of Green Tea on Obese Women and Obese Related Hormone Peptides

Taipei City Hospital

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Hyperlipidemia; Diabetes Mellitus

Treatments: Drug: Placebo; Drug: EGCG(Epigallocatechin Gallate)

Study type: Interventional

Funder types: Other

Identifiers

NCT02147041

100XDAA00110 (Other Grant/Funding Number)

Details and patient eligibility

About

The aim of this study is to examine the therapeutic effect of green tea extract on obese women and the correlation analysis between traditional Chinese medicine syndrome and obese related hormone peptides.

Full description

Obesity has become a noticeable and worldwide public health problem recently. According to the WHO survey in 2005, 1.6 billion and 400 million adults were found overweight and obese, respectively. In Taiwan, there are more than 30% found overweight in the national survey in 2009. Compare with the ones done in 1999 and 2005, a rising trend of the prevalence of obesity is found. Furthermore, the incidence and prevalence of obesity are also increasing worldwide, especially in the developing and newly industrialized nations. In addition, obesity is related to some chronic diseases, like diabetes mellitus, hyperlipidemia and cardiovascular diseases, which are major lethal health concerns in Taiwan and many developing countries. Taken together, obesity emerges as an important issue lately. The aim of the study is to evaluate the therapeutic effect and safety of green tea extract on demographic characteristics and obesity-related hormone peptide of obese women and to establish an obesity Traditional Chinese Medicine (TCM) syndromes questionnaire, which will undergo well assessing of reliability and validity. Second, we intent to utilize the TCM syndromes and Quality of Life (SF-12, WHO) questionnaire to 200 obesity women for the correlation analysis of TCM syndromes, obesity related hormone peptides and quality of life. The results of this study are expected to assess the effect and safety of green tea extract on obese women and improve the scientific diagnosis of TCM with a quantitative measurement by this questionnaire.

Enrollment: 92 estimated patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged between 20 and 60 years old women
• Chinese
• body mass index (BMI) > 27 kg/m2
• waist circumference (WC) > 80 cm
• willing to participate in and fill out the questionnaires for this trial.

Exclusion criteria

• GPT > 80 U/L, serum creatinine > 2.0 mg/dl
• breast feeding or pregnancy
• heart failure
• acute myocardial infarction
• Stroke
• any other conditions not suitable for trial as evaluated by the physician

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 2 patient groups, including a placebo group

EGCG(Epigallocatechin Gallate)

Experimental group

Description:

EGCG(Epigallocatechin Gallate)(500 mg, three times a day, 12 weeks)

Treatment:

Drug: EGCG(Epigallocatechin Gallate)

placebo

Placebo Comparator group

Description:

cellulose (500mg, three times a day, 12 weeks)

Treatment:

Drug: Placebo